Cyclomydril

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 1/12/2022
Drug Description

What is Cyclomydril and how is it used?

Cyclomydril is a prescription medicine used to treat the symptoms of Mydriasis/Cycloplegia (dilation of the pupil in your eye). Cyclomydril may be used alone or with other medications.

Cyclomydril belongs to a class of drugs called Cycloplegics/Mydriatics.

What are the possible side effects of Cyclomydril?

Cyclomydril may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • blurred vision,
  • tunnel vision,
  • seeing halos around lights,
  • eye pain,
  • fast heart rate,
  • severe headache,
  • pounding in your neck or ears,
  • anxiety,
  • fever,
  • little or no urinating,
  • flushing (warmth, redness, or tingly feeling),
  • severe constipation, and
  • weak or shallow breathing

Specific to children and infants:

  • confusion,
  • changes in behavior,
  • hallucinations,
  • speech problems,
  • difficulty recognizing people,
  • restlessness,
  • excitement,
  • loss of balance or coordination,
  • seizures,
  • feeding problems, and
  • loss of appetite

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Cyclomydril include:

  • dry mouth, nose, or throat
  • decreased sweating, and
  • sensitivity to light

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Cyclomydril. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

CYCLOMYDRIL® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) is a mydriatic prepared as a sterile topical ophthalmic solution. The active ingredients are represented by the chemical structures:

Cyclopentolate hydrochloride - Structural Formula  Illustration

Established name: Cyclopentolate Hydrochloride
Chemical name: 2- (Dimethylamino) ethyl 1-hydroxy- α-phenylcyclopentaneacetate hydrochloride

Phenylephrine Hydrochloride - Structural Formula  Illustration

Established name: Phenylephrine Hydrochloride
Chemical name: 3-hydroxy -α [(methylamino) - methyl]-, Benzenemethanol, hydrochloride (R)-.

Each mL contains : Active: cyclopentolate hydrochloride 0.2%, phenylephrine hydrochloride 1%. Preservative: benzalkonium chloride 0.01%. Inactives : edetate disodium, boric acid, hydrochloric acid and /or sodium carbonate (to adjust pH), purified water.

Indications & Dosage

2 pharmacies near 20147 have coupons for Cyclomydril (Brand Names:Cyclomydril for 2ML of 0.2-1%)

Walgreens
Walgreens
$46.79

Est. Regular Price

$35.96

with free coupon

View Coupon
Harris Teeter Pharmacy
Harris Teeter Pharmacy
$46.79

Est. Regular Price

$37.05

with free coupon

View Coupon

INDICATIONS

For the production of mydriasis.

DOSAGE AND ADMINISTRATION

Instill one drop in each eye every five to ten minutes. To minimize systemic absorption, apply pressure over the nasolacrimal sac for two to three minutes following instillation. Observe infants closely for at least 30 minutes.

HOW SUPPLIED

CYCLOMYDRIL® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) is supplied as a sterile solution in 2 mL and 5 mL, in plastic DROP-TAINER® dispensers.

2 mL NDC 0065-0359-02
5 mL NDC 0065-0359-05

Storage

Store at 8°C to 25°C (46°F - 77°F)

Distributed by: ALCON LABORATORIES, INC., 6201 South Freeway, Fort Worth, Texas 76134-2099. Revised: Jun 2018

SLIDESHOW

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Side Effects & Drug Interactions

SIDE EFFECTS

Ocular

The following ocular adverse experiences have been associated with the use of CYCLOMYDRIL (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution): increased intraocular pressure, burning/irritation upon instillation, photophobia, blurred vision and superficial punctate keratitis.

Nonocular

Use of cyclopentolate hydrochloride has been associated with psychotic reactions and behavioral disturbances in children. These disturbances include ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and place, and failure to recognize people. This drug produces reactions similar to those of other adrenergic and anticholinergic drugs; however, the central nervous system manifestations as noted above are most common. Other manifestations of adrenergic and anticholinergic topical ophthalmic drugs include tachycardia, hyperpyrexia, hypertension, vasodilation, urinary retention, diminished gastrointestinal motility, and decreased secretion in salivary and sweat glands, pharynx, bronchi and nasal passages. Severe manifestations of toxicity include coma, medullary paralysis and death.

DRUG INTERACTIONS

Cyclopentolate may interfere with the ocular anti-hypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.

Warnings & Precautions

WARNINGS

FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION. The use of this combination may have an adverse effect on individuals suffering from cardiovascular disease, hypertension, and hyperthyroidism, and it may cause CNS disturbances. Infants are especially prone to CNS and cardiopulmonary side effects from cyclopentolate. Observe infants closely for at least 30 minutes.

Mydriatics may produce a transient elevation of intraocular pressure.

PRECAUTIONS

General

The lacrimal sac should be compressed by digital pressure for two to three minutes after instillation to reduce excessive systemic absorption. Caution should be observed when considering use of this medication in the presence of Down's syndrome and in those predisposed to angle-closure glaucoma. The effect of long-term use of this preparation has not been established, therefore, it should be restricted to short-term use.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

There have been no long-term studies done using cyclopentolate hydrochloride and/or phenylephrine hydrochloride in animals to evaluate carcinogenic potential.

Pregnancy

Animal reproduction studies have not been conducted with cyclopentolate hydrochloride and/or phenylephrine hydrochloride. It is also not known whether cyclopentolate hydrochloride and/or phenylephrine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. CYCLOMYDRIL (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether these drugs are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when CYCLOMYDRIL (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) is administered to a nursing woman.

Pediatric Use

Use of cyclopentolate has been associated with psychotic reactions and behavioral disturbances in pediatric patients. Increased susceptibility to cyclopentolate has been reported in infants, young children, and in children with spastic paralysis or brain damage. These disturbances include ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and place, and failure to recognize people. Feeding intolerance may follow ophthalmic use of this product in infants. It is recommended that feeding be withheld for 4 hours after examination. Observe infants closely for at least 30 minutes (see PRECAUTIONS).

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Overdosage & Contraindications

OVERDOSE

Excessive dosage may produce behavioral disturbances, tachycardia, hyperpyrexia, hypertension, elevated intraocular pressure, vasodilation, urinary retention, diminished gastrointestinal motility and decreased secretion in salivary and sweat glands, pharynx, bronchi and nasal passages. Patients exhibiting signs of overdosage should receive supportive care and monitoring.

CONTRAINDICATIONS

Do not use in patients with untreated narrow-angle glaucoma or with untreated anatomically narrow angles or where there is hypersensitivity to any component of this preparation.

Clinical Pharmacology

CLINICAL PHARMACOLOGY

Cyclopentolate hydrochloride is an anticholinergic drug and phenylephrine hydrochloride is an adrenergic drug. This combination induces mydriasis that is greater than that of either drug alone at its respective concentration. The concentrations of cyclopentolate hydrochloride and phenylephrine hydrochloride have been selected to induce mydriasis with little accompanying cycloplegia. Heavily pigmented irides may require more doses than lightly pigmented irides.

Medication Guide

PATIENT INFORMATION

Do not touch dropper tip to any surface, as this may contaminate the solution. Patient should be advised not to drive or engage in hazardous activities while pupils are dilated. Patient may experience sensitivity to light and should protect eyes in bright illumination during dilation. Parents should be warned not to get this preparation in their child's mouth and to wash their own hands and the child's hands following administration. Feeding intolerance may follow ophthalmic use of this product in infants. It is recommended that feeding be withheld for four (4) hours after examination.

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Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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